BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 18774483 · Received February 24, 2024

    Report

    Report Number
    3010034862-2024-00001
    Event Type
    Injury
    Date Received
    February 24, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 18, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MISTREATMENT WAS CAUSED BY A USE ERROR. RAYSTATION/RAYPLAN SUPPORTS MATERIAL OVERRIDES TO IMPROVE DOSE CALCULATION ACCURACY WHEN IMAGE DATA CONTAINS IMPLANTS OR ARTIFACTS. THE USER CAN SELECT FROM PRE-DEFINED MATERIALS IN THE RAYSTATION/RAYPLAN DEFAULT MATERIAL LIST AND / OR USER-DEFINED MATERIALS THAT CAN BE ADDED TO THE LIST. THE CHEMICAL ELEMENT SILICON IS INCLUDED IN THE RAYSTATION/RAYPLAN DEFAULT MATERIAL LIST. IN RAYSTATION/RAYPLAN 2023B AND HIGHER, SILICON IS DISPLAYED AS "SILICON [SI]" IN THE DEFAULT MATERIAL LIST. IN EARLIER VERSIONS IT APPEARS AS "SILICON". THE CLINIC HAS STATED THAT THERE IS NO SIGNIFICANT RISK TO THE PATIENT'S LIFE, BUT PNEUMONITIS IS A POSSIBILITY SINCE THE LUNG WAS IN THE OVERDOSE TREATMENT FIELD. THE HEART DOSE WAS ALSO HIGHER THAN PLANNED, BUT STILL NOT EXPECTED TO BE A MAJOR PROBLEM ACCORDING TO THE CLINIC'S ASSESSMENT. THE REVIEW AND APPROVAL BY A QUALIFIED USER BEFORE A TREATMENT PLAN IS USED FOR CLINICAL PURPOSES IS A FUNDAMENTAL SAFETY BARRIER, EXPLICITLY REQUIRED BY THE RADIOTHERAPY TREATMENT PLANNING SYSTEM SAFETY STANDARD, IEC 62083. THE RAYSTATION INSTRUCTIONS FOR USE SPECIFICALLY REQUIRES A USER REVIEW OF REGIONS OF INTERESTS, INPUT TO DOSE CALCULATION, AND RESULTING TREATMENT PLANS.

    Description of Event or Problem · 0

    PATIENT MISTREATMENT HAS OCCURRED DUE TO USE ERROR. THE PATIENT WAS TREATED 23 OUT OF 29 FRACTIONS WITH A PROTON PLAN USING MATERIAL OVERRIDE WITH SILICON, SI, WHEN THE INTENTION WAS TO REPRESENT A SILICONE POLYMER, LEADING TO A HIGHER DOSE THAN INTENDED.IN RAYSTATION, THE USER CAN DEFINE VOLUMES WHERE THE IMAGE DATA USED FOR DOSE CALCULATION IS OVERRIDDEN WITH A BULK DENSITY ASSIGNMENT. THIS IS CALLED MATERIAL OVERRIDE AND MAY BE REQUIRED WHEN THE PATIENT HAS IMPLANTS OF MATERIALS THAT ARE NOT WELL REPRESENTED IN THE IMAGE DATA OR WHEN THERE ARE ARTIFACTS IN THE IMAGES. USING MATERIAL OVERRIDE IN SUCH SITUATIONS IMPROVES THE DOSE CALCULATION ACCURACY.IF AN INCORRECT MATERIAL OVERRIDE IS ASSIGNED, THE ESTIMATED RADIATION DOSE CALCULATED BY RAYSTATION MAY DIFFER FROM THE DELIVERED DOSE. IN THE REPORTED EVENT, THE PLANNER SELECTED "SILICON", I.E. THE CHEMICAL ELEMENT SI, WHEN CREATING A MATERIAL OVERRIDE FOR A SILICONE POLYMER IMPLANT. THE PURE SILICON IN THE MATERIAL LIST HAS A DENSITY OF 2.33 G/CM 3 WHILE THE CORRECT DENSITY OF SILICONE POLYMER IS CLOSE TO WATER. THE INCORRECT DENSITY LED TO A RADIATION OVERDOSE TO THE PATIENT. THE ERROR WAS DETECTED AFTER 23 OUT OF 29 FRACTIONS WERE DELIVERED.THERE WAS NO MALFUNCTION. MISTREATMENT WAS CAUSED BY A USER MISTAKE, CONFUSING SILICON, SI, WITH SILICONE POLYMER.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2024-00001 (B)(6) PATIENT MISTREATMENT NY PROTON. PATIENT MISTREATMENT HAS OCCURRED DUE TO USE ERROR. THE PATIENT WAS TREATED 23 OUT OF 29 FRACTIONS WITH A PROTON PLAN USING MATERIAL OVERRIDE WITH SILICON, SI, WHEN THE INTENTION WAS TO REPRESENT A SILICONE POLYMER, LEADING TO A HIGHER DOSE THAN INTENDED. IN RAYSTATION, THE USER CAN DEFINE VOLUMES WHERE THE IMAGE DATA USED FOR DOSE CALCULATION IS OVERRIDDEN WITH A BULK DENSITY ASSIGNMENT. THIS IS CALLED MATERIAL OVERRIDE AND MAY BE REQUIRED WHEN THE PATIENT HAS IMPLANTS OF MATERIALS THAT ARE NOT WELL REPRESENTED IN THE IMAGE DATA OR WHEN THERE ARE ARTIFACTS IN THE IMAGES. USING MATERIAL OVERRIDE IN SUCH SITUATIONS IMPROVES THE DOSE CALCULATION ACCURACY. IF AN INCORRECT MATERIAL OVERRIDE IS ASSIGNED, THE ESTIMATED RADIATION DOSE CALCULATED BY RAYSTATION MAY DIFFER FROM THE DELIVERED DOSE. IN THE REPORTED EVENT, THE PLANNER SELECTED "SILICON", I.E. THE CHEMICAL ELEMENT SI, WHEN CREATING A MATERIAL OVERRIDE FOR A SILICONE POLYMER IMPLANT. THE PURE SILICON IN THE MATERIAL LIST HAS A DENSITY OF 2.33 G/CM 3 WHILE THE CORRECT DENSITY OF SILICONE POLYMER IS CLOSE TO WATER. THE INCORRECT DENSITY LED TO A RADIATION OVERDOSE TO THE PATIENT. THE ERROR WAS DETECTED AFTER 23 OUT OF 29 FRACTIONS WERE DELIVERED. THERE WAS NO MALFUNCTION. MISTREATMENT WAS CAUSED BY A USER MISTAKE, CONFUSING THE CHEMICAL ELEMENT SILICON, SI, WITH SILICONE GEL POLYMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260159 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other